Senior Clinical Research Associate

JR Italy; Prato; In loco; EUR 50.000 - 70.000; Tempo pieno

Descrizione del lavoro

A leading medical technology company in Prato is seeking a Senior Clinical Research Associate to conduct monitoring visits ensuring compliance with regulatory standards. The ideal candidate will have at least 5 years of experience in clinical trials within the medical device or pharma industry. This role requires strong communication, organizational skills, and knowledge of relevant guidelines. Competitive compensation and professional development opportunities are provided.

Competenze

• Minimum 5 years of work experience as a clinical trial monitor.
• Experience in medical device or pharma industry required.
• Knowledge of vascular interventional cardiology advantageous.

Mansioni

• Conduct monitoring within timelines and according to plans.
• Evaluate site practices and escalate issues.
• Conduct monitoring visits as per the monitoring plan.
• Ensure compliance with local regulations.
• Mentor new staff and support process improvements.

Conoscenze

Knowledge of MDR

Knowledge of ISO 14155

Knowledge of ICH/GCP guidelines

Excellent communication skills

Strong organizational skills

Proficiency with MS Office

Formazione

Bachelor’s or higher in life sciences

Relevant field qualification

Strumenti

MS Office

Descrizione del lavoro

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Senior Clinical Research Associate, Prato

Client: Teleflex

Location: Prato, Italy

Job Category: Other

EU work permit required: Yes

Job Reference: 8556790222002585600337140

Job Views: 2

Posted: 27.08.2025

Expiry Date: 11.10.2025

Job Description:

POSITION SUMMARY: The Senior Clinical Research Associate (Senior CRA) is responsible for scheduling and conducting on-site and remote monitoring visits in compliance with applicable regulatory standards (MDR, ISO 14155, ICH/GCP guidelines, Teleflex procedures, and IRB/EC policies). The Senior CRA conducts monitoring visits as identified by the monitoring plan, study team, or department needs to evaluate data accuracy and subject safety. The Senior CRA must identify issues, present findings, provide retraining, and communicate with the study team. A minimum of 5 years of work experience as a clinical trial monitor is required. The Senior CRA also assists with training and developing monitoring tools and procedures.

CULTURE:

Customer Experience – Representing Teleflex in a customer-facing role is a significant responsibility.

All colleagues are expected to perform professionally, ethically, and with high service standards to strengthen the Teleflex brand.

Continuous Improvement – Demonstrates initiative to identify and address process and performance gaps, developing solutions for improvement.

Culture and Values – Embodies Teleflex values, ensuring a fair, ethical, and compliant work environment, and collaborates effectively across functions.

PRINCIPAL RESPONSIBILITIES

• Conduct monitoring within timelines and according to plans and procedures.
• Coordinate with research staff to schedule and perform monitoring visits.
• Evaluate site practices, escalate issues, and assist in resolving quality concerns.
• Prepare for visits, ensuring thoroughness and efficiency.
• Perform monitoring activities per SOPs, guidelines, and regulations.
• Complete documentation accurately and timely.
• Present findings, provide training, and resolve data queries.
• Ensure compliance with safety reporting requirements and local regulations.
• Support in audits, training, and study-related projects.
• Mentor new staff and support process improvements.

EDUCATION / EXPERIENCE REQUIREMENTS:

• Bachelor’s or higher in life sciences, nursing, or related fields, or equivalent qualification.
• At least 5 years’ experience as a CRA in medical device or pharma industry.
• Knowledge of vascular interventional cardiology or peripheral vascular intervention is advantageous.

SPECIALIZED SKILLS & OTHER REQUIREMENTS:

• Strong knowledge of MDR, ISO 14155, ICH/GCP guidelines.
• Ability to train and mentor staff, maintain composure, and manage priorities.
• Excellent communication, organizational, and documentation skills.
• Proficient with MS Office and remote work tools.